Cost Sharing, Acute Coronary SyndromePhase 4ARTEMISNCT02406677

Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study

A Phase 4 study testing Study voucher card in people with Cost Sharing, Acute Coronary Syndrome, run by AstraZeneca at 272 sites in 2 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

Search all trials

Trial summary

Who is it for?: Ages 18 to 130 years
Conditions the study is for: Cost Sharing, Acute Coronary Syndrome
What is being tested?: Study voucher card
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 11,001 participants
Where: 272 sitesin 2 countries
Study dates: 5 Jun 2015to 23 Oct 2017
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 130 years
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

Patients are eligible to be included in the study if they meet all of the following criteria:
are ≥ 18 years of age
have been diagnosed with STEMI or NSTEMI during the index hospitalization
be treated with a P2Y12 receptor inhibitor at the time of enrollment
have U.S. based health insurance coverage with prescription drug benefit
have been fully informed and are able to provide written consent for longitudinal follow-up

Who cannot join

Patients are excluded if they meet any of the following criteria:
have a history of prior intracranial hemorrhage
have any contraindications to P2Y12 receptor inhibitor therapy at discharge
involvement in another research study that specifies the type and duration of P2Y12 receptor inhibitor use within the next 12 months.
have a life expectancy of less than one year
have plans to move outside the US in the next year

Trial locations and contacts

272 sites in 2 countries.

Country

City, postcode or hospital

272 sites in 2 countries

United States271 sites

Research Site
Abington, Pennsylvania, 19001
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Albany, New York, 12205
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Alexandria, Louisiana, 71301
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Allentown, Pennsylvania, 18103
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Alpena, Michigan, 49707
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Anchorage, Alaska, 99508
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Anderson, South Carolina, 29621
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Ann Arbor, Michigan, 48109
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Annapolis, Maryland, 21401
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Asheville, North Carolina, 28803
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Athens, Georgia, 30606
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Atlanta, Georgia, 30303
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Atlanta, Georgia, 30342
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Augusta, Georgia, 30912
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Aurora, Colorado, 80012
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Aurora, Colorado, 80045
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Aurora, Illinois, 60504
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Baltimore, Maryland, 21215
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Baltimore, Maryland, 21229
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Bay City, Michigan, 48708
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Belleville, Illinois, 62226
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Bend, Oregon, 97701
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Bethesda, Maryland, 20814
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Billings, Montana, 59101
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Birmingham, Alabama, 35294
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Bloomington, Indiana, 47403
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Bossier City, Louisiana, 71111
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Boston, Massachusetts, 02118
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Boston, Massachusetts, 2215
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Boynton Beach, Florida, 33435
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Bradenton, Florida, 34205
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Bradenton, Florida, 34209
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Bridgeport, Connecticut, 06610
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Bridgeton, Missouri, 63044
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Bridgewater, New Jersey, 08807
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Brighton, Massachusetts, 2135
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Burlington, Vermont, 05401
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Camp Hill, Pennsylvania, 17011
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Canton, Ohio, 447018
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Chambersburg, Pennsylvania, 17201
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Charleston, South Carolina, 29401
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Charleston, South Carolina, 29425
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Charlottesville, Virginia, 22908
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Chicago, Illinois, 60612
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Chicago, Illinois, 60637
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Cincinnati, Ohio, 45267
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Cleveland, Ohio, 44106
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Clinton, Maryland, 20735
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Coeur d'Alene, Idaho, 83814
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Colorado Springs, Colorado, 80907
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Columbia, Maryland, 21044
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Columbia, South Carolina, 29203
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Columbia, South Carolina, 29204
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Cooperstown, New York, 13326
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Cottonwood, Arizona, 86326
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Cumming, Georgia, 30041
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Dallas, Texas, 75231
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Danbury, Connecticut, 6810
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Danville, Pennsylvania, 17822
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Davenport, Iowa, 52803
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Dayton, Ohio, 45406
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Daytona Beach, Florida, 32114
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Denver, Colorado, 80204
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Detroit, Michigan, 48202
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Detroit, Michigan, 48236
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Doylestown, Pennsylvania, 18901
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Duluth, Minnesota, 55805
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Durham, North Carolina, 27710
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Englewood, Indiana, 7631
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Escondido, California, 92025
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Fayetteville, Arkansas, 72703
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Fenton, Missouri, 63026
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Flagstaff, Arizona, 86001
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Flemington, New Jersey, 08822
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Flint, Michigan, 48532
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Fort Smith, Arkansas, 72901
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Gainesville, Florida, 32607
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Gastonia, North Carolina, 28054
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Grand Blanc, Michigan, 48439
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Grand Forks, North Dakota, 58201
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Grand Rapids, Michigan, 49503
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Green Bay, Wisconsin, 54301
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Greenwood, South Carolina, 29646
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Haddon Heights, New Jersey, 08035
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Haddon Heights, New Jersey, 8035
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Hattiesburg, Mississippi, 39401
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High Point, North Carolina, 27262
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Hollywood, Florida, 33021
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Honolulu, Hawaii, 96813
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Houston, Texas, 77030
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Houston, Texas, 77074
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Hudson, Florida, 34667
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Huntington Beach, California, 92648
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Huntsville, Alabama, 35613
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Hyannis, Massachusetts, 02601
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Indianapolis, Indiana, 46237
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Indianapolis, Indiana, 46250
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Indianapolis, Indiana, 46290
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Iowa City, Iowa, 52242
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Jackson, Michigan, 39216
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Jackson, Tennessee, 38301
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Jacksonville, Florida, 32204
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Jacksonville, Florida, 32207
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Jacksonville, Florida, 32216
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Jacksonville, Florida, 32258
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Jacksonville Beach, Florida, 32250
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Johnson City, New York, 13790
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Joliet, Illinois, 60435
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Jonesboro, Arkansas, 72401
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Joplin, Missouri, 64804
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Kansas City, Missouri, 64111
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Kansas City, Missouri, 64114
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Kettering, Ohio, 45429
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Knoxville, Tennessee, 37934
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La Crosse, Wisconsin, 54601
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Lakeland, Florida, 33805
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Lancaster, Pennsylvania, 17603
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Largo, Florida, 33770
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Las Vegas, Nevada, 89128
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Lawrenceville, Georgia, 30045
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Lexington, Kentucky, 40503
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Lincoln, Nebraska, 68506
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Lincoln, Nebraska, 68526
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Little Rock, Arkansas, 72211
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Loma Linda, California, 92354
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Los Angeles, California, 90048
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Los Angeles, California, 90095
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Louisville, Kentucky, 40202
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Louisville, Kentucky, 40205
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Louisville, Kentucky, 40292
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Lumberton, North Carolina, 28358
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Lynchburg, Virginia, 24501
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Macon, Georgia, 31210
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Macon, Georgia, 31217
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Marietta, Georgia, 30060
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Marquette, Michigan, 49855
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Memphis, Tennessee, 38104
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Memphis, Tennessee, 38120
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Miami, Florida, 33133
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Middleburg Heights, Ohio, 44130
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Milwaukee, Wisconsin, 53211
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Milwaukee, Wisconsin, 53215
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Milwaukee, Wisconsin, 53226
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Minneapolis, Minnesota, 55407
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Mobile, Alabama, 36608
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Mobile, Alabama, 36617
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Moorestown, New Jersey, 08057
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Morehead City, North Carolina, 28557
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Morgantown, West Virginia, 26505
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Mount Clemens, Michigan, 48043
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Muncie, Indiana, 47303
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Munster, Indiana, 46321
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New Braunfels, Texas, 78130
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New Haven, Connecticut, 06519
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New Orleans, Louisiana, 70121
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New York, New York, 10029
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Newark, New Jersey, 07102
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Norfolk, Virginia, 23507
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North Kansas City, Missouri, 64116
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Northridge, California, 91328
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Oak Ridge, Tennessee, 37830
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Ocala, Florida, 34474
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Oklahoma City, Oklahoma, 73112
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Oklahoma City, Oklahoma, 73120
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Omaha, Nebraska, 68105
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Omaha, Nebraska, 68131
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Omaha, Nebraska, 68154
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Orlando, Florida, 32803
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Overland Park, Kansas, 66209
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Palestine, Texas, 75801
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Panama City, Florida, 32401
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Pasadena, California, 91105
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Paterson, New Jersey, 07503
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Pensacola, Florida, 32501
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Pensacola, Florida, 32504
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Peoria, Illinois, 61614
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Petoskey, Michigan, 49770
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Philadelphia, Pennsylvania, 19102
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Phoenix, Arizona, 85008
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Pinehurst, North Carolina, 28374
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Pittsburgh, Pennsylvania, 15212
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Pittsburgh, Pennsylvania, 15232
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Plano, Texas, 75093
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Pomona, New Jersey, 08240
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Pontiac, Michigan, 48341
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Portland, Oregon, 97062
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Poughkeepsie, New York, 12601
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Puyallup, Washington, 98372
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Racine, Wisconsin, 53405
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Raleigh, North Carolina, 27607
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Raleigh, North Carolina, 27610
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Rapid City, South Dakota, 57701
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Reno, Nevada, 89502
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Reno, Nevada, 89503
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Renton, Washington, 98055
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Richmond, Indiana, 47375
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Richmond, Virginia, 23229
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Ridgewood, New Jersey, 07450
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Riverside, California, 92501
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Roanoke, Virginia, 24014
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Rochester, New York, 14621-3001
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Rockford, Illinois, 61103
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Rockford, Illinois, 61107
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Rockport, Maine, 04856
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Rockville, Maryland, 20850
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Round Rock, Texas, 78665
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Safety Harbor, Florida, 34695
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Saginaw, Michigan, 48602
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Saint Charles, Missouri, 63301
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Saint Cloud, Minnesota, 56303
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Saint Joseph, Michigan, 49085
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Saint Paul, Minnesota, 55101
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Saint Paul, Minnesota, 55102
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Salinas, California, 93901
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Salisbury, Maryland, 21804
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San Antonio, Texas, 78201
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Sarasota, Florida, 34239
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Sayre, Pennsylvania, 18840
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Schenectady, New York, 12308
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Scranton, Pennsylvania, 18508
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Sellersville, Pennsylvania, 18960
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Shreveport, Louisiana, 71103
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South Bend, Indiana, 46601
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Southfield, Michigan, 48075
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Spokane, Washington, 99204
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Springfield, Illinois, 62701
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St Louis, Missouri, 63110
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St Louis, Missouri, 63117
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St Louis, Missouri, 63128
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St Louis, Missouri, 63131-2374
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St Louis, Missouri, 63136
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St Louis, Missouri, 63367
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St. Petersburg, Florida, 33701
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St. Petersburg, Florida, 33709
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St. Petersburg, Florida, 33713
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Stamford, Connecticut, 06904
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Staten Island, New York, 10310
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Stockton, California, 95210
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Stony Brook, New York, 11794
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Suwanee, Georgia, 30024
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Tallahassee, Florida, 32308
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Tampa, Florida, 33607
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Tampa, Florida, 33613
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Teaneck, New Jersey, 07666
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Temple, Texas, 76508
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Thousand Oaks, California, 91360
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Toledo, Ohio, 43615
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Torrance, California, 90505-5073
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Tualatin, Oregon, 97062
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Urbana, Illinois, 51801
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Utica, New York, 13501
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Valhalla, New York, 10595
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Valparaiso, Indiana, 46383
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Vista, California, 92083
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Voorhees Township, New Jersey, 08043
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Waco, Texas, 76712
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Warren, Michigan, 48093
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Warwick, Rhode Island, 02886
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Waukesha, Wisconsin, 53188
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Webster, Texas, 77598
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West Columbia, South Carolina, 29169
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West Des Moines, Iowa, 50266
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West Reading, Pennsylvania, 19611
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Wilkes-Barre, Pennsylvania, 18711
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Wilmington, North Carolina, 28403
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Winchester, Virginia, 22601
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Winston-Salem, North Carolina, 27104
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Winter Haven, Florida, 33881
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Worcester, Massachusetts, 1655
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York, Pennsylvania, 17403
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York, Pennsylvania, 17405

Other trials in United States

Puerto Rico1 site

Research Site
Caguas, 00725

Other trials in Puerto Rico

About this study

Current patterns of P2Y12 receptor inhibitor use provide an excellent opportunity to test the impact of copayment reduction on clinician choice of medication, patient adherence, and clinical outcomes. The ARTEMIS trial is a practical multicenter, cluster- randomized clinical trial that will assess the impact of copayment reduction by equalizing the copayment of clopidogrel and ticagrelor. ARTEMIS will assess prescribing patterns, patient medication adherence, and clinical outcomes up to one year. We hypothesize that reducing out--of--pocket cost for P2Y12 receptor inhibitor will lead to improved adherence. Additionally, copayment reduction of both generic and brand antiplatelet agents may lead to a reduction in MACE risk. This is in part due to greater adherence to an evidence--based secondary prevention medication. Additionally the reduction in MACE may reflect greater selection of a more potent antiplatelet agent that has been shown to reduce MACE in randomized clinical trials, as provider choice of antiplatelet therapy will be primarily driven by risk- benefit assessment rather than the cost burden to the patient.

Read the detailed description

ARTEMIS is a prospective, cluster-randomized clinical trial that will evaluate whether patient copayment elimination significantly influences antiplatelet therapy selection and long-term adherence, as well as patient outcomes and overall cost of care after acute myocardial infarction. Approximately 11,000 patients with ST-elevation myocardial infarction (STEMI) or non-STEMI (NSTEMI) will be enrolled at the approximately 300 hospitals in this study. Study sites selected for ARTEMIS will be geographically diverse, and will represent a diversity of hospital types and capabilities (e.g., teaching hospital, community hospital, etc). After institutional review board (IRB) approval of the study, each hospital will be randomized into either the intervention arm or the control arm. Hospitals randomized to the intervention arm will have the opportunity to offer enrolled patients either clopidogrel (generic P2Y12 receptor inhibitor option) or ticagrelor (brand P2Y12 receptor inhibitor option) without patient contribution to copayment in the next 12 months after the index MI discharge. Hospitals in the control arm will provide care per usual clinical routine. Notably, for both intervention and control arms, all patient management decisions (including the choice of antiplatelet therapy) are completely at the discretion of the care providers. Duration of antiplatelet therapy will also be at the discretion of care providers. All enrolled patients will be followed up to 15 months after index MI discharge to collect data on longitudinal treatment patterns and outcomes. Primary and secondary endpoints will be assessed at 12 months. An additional three months of follow up will assess for antiplatelet persistence and clinical events after discontinuation of the copayment intervention. Centralized follow-up will be conducted every 3 months via telephone or web-based contact.

Conditions: Cost Sharing, Acute Coronary Syndrome
Being tested: Study voucher card
Keywords: Acute Coronary Syndromes, ACS, Myocardial Infarction, STEMI, NSTEMI, MI, Co-Payments, Copay, Cost Sharing
Medical subject headings: Acute Coronary Syndrome, Myocardial Infarction, ST Elevation Myocardial Infarction, Non-ST Elevated Myocardial Infarction

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study voucher cardOther
Study voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor

Study groups in NCT02406677
Study group	Role	What they receive
Copayment Intervention Arm	Experimental	Sites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor. Receives: Other: Study voucher card
Usual Care Arm	No intervention	For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.

What is being measured

The primary outcome is the main question the study is designed to answer.

Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events
To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge.
Measured: 12 months
Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor
To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge.
Measured: 12 months

Secondary outcomes (1)

P2Y12 Receptor Inhibitor Selection
To evaluate whether reducing patient copayments for both generic and brand P2Y12 receptor inhibitor options affects medication selection at discharge.
Measured: 12 months

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

5 Jun 201523 Oct 2017

First posted2 Apr 2015 (estimated)
Study start5 Jun 2015
Primary completion23 Oct 2017
Study completion23 Oct 2017

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Publications (7)Papers the sponsor has linked to this study.
Other trials for Cost Sharing, Acute Coronary SyndromeStudies of the same condition, open and under way.
More trials run by AstraZenecaThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Enrolment: 11,001 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02406677
Sponsor's protocol ID: D5130R00030
Acronym: ARTEMIS
Status last verified: Sep 2019
First submitted: 30 Mar 2015
Last updated: 1 Oct 2019
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Publications

Rymer JA, Wegermann ZK, Kaltenbach LA, Webb LE, Peterson ED, Wang TY. Challenge in Predicting Persistence to P2Y12 Inhibitors: A Perspective From the ARTEMIS Trial. J Am Heart Assoc. 2023 Jun 20;12(12):e029063. doi: 10.1161/JAHA.122.029063. Epub 2023 Jun 10.
PubMed 37301758
Rymer JA, Kaltenbach LA, Peterson ED, Cohen DJ, Fonarow GC, Choudhry NK, Henry TD, Cannon CP, Wang TY. Does the Effectiveness of a Medicine Copay Voucher Vary by Baseline Medication Out-Of-Pocket Expenses? Insights From ARTEMIS. J Am Heart Assoc. 2022 Oct 18;11(20):e026421. doi: 10.1161/JAHA.122.026421. Epub 2022 Oct 17.
PubMed 36250667
Fanaroff AC, Peterson ED, Kaltenbach LA, Anstrom KJ, Fonarow GC, Henry TD, Cannon CP, Choudhry NK, Cohen DJ, Atreja N, Bhalla N, Eudicone JM, Wang TY. Copayment Reduction Voucher Utilization and Associations With Medication Persistence and Clinical Outcomes: Findings From the ARTEMIS Trial. Circ Cardiovasc Qual Outcomes. 2020 May;13(5):e006182. doi: 10.1161/CIRCOUTCOMES.119.006182. Epub 2020 May 12.
PubMed 32393129
Doll JA, Kaltenbach LA, Anstrom KJ, Cannon CP, Henry TD, Fonarow GC, Choudhry NK, Fonseca E, Bhalla N, Eudicone JM, Peterson ED, Wang TY. Impact of a Copayment Reduction Intervention on Medication Persistence and Cardiovascular Events in Hospitals With and Without Prior Medication Financial Assistance Programs. J Am Heart Assoc. 2020 Apr 21;9(8):e014975. doi: 10.1161/JAHA.119.014975. Epub 2020 Apr 17.
PubMed 32299284
Fanaroff AC, Peterson ED, Kaltenbach LA, Cannon CP, Choudhry NK, Henry TD, Anstrom KJ, Cohen DJ, Fonseca E, Khan ND, Fonarow GC, Wang TY. Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill: A Secondary Analysis of the Cluster Randomized ARTEMIS Trial. JAMA Cardiol. 2020 May 1;5(5):532-539. doi: 10.1001/jamacardio.2020.0125.
PubMed 32129795
Fanaroff AC, Peterson ED, Kaltenbach LA, Cannon CP, Choudhry NK, Henry TD, Anstrom KJ, Cohen DJ, Fonseca E, Khan ND, Fonarow GC, Wang TY. Association of a P2Y12 Inhibitor Copayment Reduction Intervention With Persistence and Adherence With Other Secondary Prevention Medications: A Post Hoc Analysis of the ARTEMIS Cluster-Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 1;5(1):38-46. doi: 10.1001/jamacardio.2019.4408.
PubMed 31721978
Wang TY, Kaltenbach LA, Cannon CP, Fonarow GC, Choudhry NK, Henry TD, Cohen DJ, Bhandary D, Khan ND, Anstrom KJ, Peterson ED. Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction: The ARTEMIS Randomized Clinical Trial. JAMA. 2019 Jan 1;321(1):44-55. doi: 10.1001/jama.2018.19791.
PubMed 30620370

Study at a glance

From the registry record, last updated by the sponsor on 1 Oct 2019. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Affordability and Real-world Antiplatelet Treatment Effectiveness After Myocardial Infarction Study
ClinicalTrials.gov ID: NCT02406677
Acronym / sponsor ID: ARTEMIS / D5130R00030
Conditions: Cost Sharing, Acute Coronary Syndrome
Keywords: Acute Coronary Syndromes, ACS, Myocardial Infarction, STEMI, NSTEMI, MI, Co-Payments, Copay, Cost Sharing
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 11,001 participants (actual)
Lead sponsor: AstraZenecaIndustry (pharma, biotech, devices)
Collaborators: Duke Clinical Research Institute
Study start: 5 Jun 2015 (actual)
Primary completion: 23 Oct 2017 (actual)
Study completion: 23 Oct 2017 (actual)
First posted: 2 Apr 2015 (estimated)
Results: Posted 1 Oct 2019

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

Study design

Primary purpose: Health services research
Allocation: Randomised
Intervention model: Parallel groups
Masking: None (open label)
Number of arms: 2

Arm	Type	Receives
Copayment Intervention Arm	Experimental	Other: Study voucher cardSites in the intervention arm will provide patients with a study voucher card to offset any patient copayments or medication card for the filling of any prescriptions of clopidogrel or ticagrelor.
Usual Care Arm	No intervention	–For hospitals randomized to the control arm, all patients receive usual care and no study intervention is performed.

Who may qualify

Ages: 18 to 130 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (6 listed)

Patients are eligible to be included in the study if they meet all of the following criteria:
are ≥ 18 years of age
have been diagnosed with STEMI or NSTEMI during the index hospitalization
be treated with a P2Y12 receptor inhibitor at the time of enrollment
have U.S. based health insurance coverage with prescription drug benefit

Key exclusion criteria (6 listed)

have a history of prior intracranial hemorrhage
have any contraindications to P2Y12 receptor inhibitor therapy at discharge
involvement in another research study that specifies the type and duration of P2Y12 receptor inhibitor use within the next 12 months.
have a life expectancy of less than one year
have plans to move outside the US in the next year

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Study voucher cardStudy voucher card to offset any patient copayments or medication costs for the filling of any prescriptions of clopidogrel or ticagrelor	Other	Copayment Intervention Arm

Primary outcome

Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events
Time frame: 12 months
To determine if patient copayment reduction leads to lower risk of MACE (composite of death, MI, and stroke) at 1 year after discharge.
Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor
Time frame: 12 months
To determine if patient copayment reduction leads to higher long-term persistence of any P2Y12 receptor inhibitor at 1 year after discharge.

1 secondary outcome

P2Y12 Receptor Inhibitor Selection
Time frame: 12 months

Results and safety

Results posted to the registry on 1 Oct 2019, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Copayment Intervention Arm	6,436	6,135
Usual Care Arm	4,565	3,967

Primary outcome: Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events

Time frame: 12 months. Number (95% Confidence Interval). Unit: Percentage of Participants

Measure	Copayment Intervention Arm n = 6135	Usual Care Arm n = 3967
Value	10.17 (9.4 to 10.93)	10.93 (9.67 to 11.60)

Copayment Intervention Arm vs Usual Care Arm: Hazard Ratio (HR): 1.073 (95% CI 0.925 to 1.246), p = 0.3503, Regression, Cox

Population analysed: Primary Population

Primary outcome: Percentage of Patients With Long Term Non-persistence to P2Y12 Receptor Inhibitor

Time frame: 12 months. Number. Unit: Percentage of Patients

Measure	Copayment Intervention Arm n = 6135	Usual Care Arm n = 3967
Value	12.96	16.21

Copayment Intervention Arm vs Usual Care Arm: Odds Ratio (OR): 0.838 (95% CI 0.717 to 0.979), p = 0.0260, Regression, Logistic

Population analysed: Primary Population

1 secondary outcome is reported in the full results.

Adverse events

Time frame: Safety data was not actively collected in the ARTEMIS trial for the following reasons: • The safety profile of Brilinta (ticagrelor) is well established • ARTEMIS is a non-indication seeking interventional study that did not include a safety objective; the intervention involved co-payment only. Only Deaths were collected over the course of the 15-month study period.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Copayment Intervention Arm	0 of 0	0 of 0	16 of 6,135
Usual Care Arm	0 of 0	0 of 0	8 of 3,967

Limitations and caveats (from the sponsor): 1. Imbalances in enrollment and patient characteristics were expected in this cluster-randomized design due to differential incentives to enroll. 2. The cluster-randomized design renders the usual care arm vulnerable to potential bias to the null.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 1 Oct 2019.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Derived from this study: PubMed 37301758Rymer JA, Wegermann ZK, Kaltenbach LA, Webb LE, Peterson ED, Wang TY. Challenge in Predicting Persistence to P2Y12 Inhibitors: A Perspective From the ARTEMIS Trial. J Am Heart Assoc. 2023 Jun 20;12(12):e029063. doi: 10.1161/JAHA.122.029063. Epub 2023 Jun 10.
Derived from this study: PubMed 36250667Rymer JA, Kaltenbach LA, Peterson ED, Cohen DJ, Fonarow GC, Choudhry NK, Henry TD, Cannon CP, Wang TY. Does the Effectiveness of a Medicine Copay Voucher Vary by Baseline Medication Out-Of-Pocket Expenses? Insights From ARTEMIS. J Am Heart Assoc. 2022 Oct 18;11(20):e026421. doi: 10.1161/JAHA.122.026421. Epub 2022 Oct 17.
Derived from this study: PubMed 32393129Fanaroff AC, Peterson ED, Kaltenbach LA, Anstrom KJ, Fonarow GC, Henry TD, Cannon CP, Choudhry NK, Cohen DJ, Atreja N, Bhalla N, Eudicone JM, Wang TY. Copayment Reduction Voucher Utilization and Associations With Medication Persistence and Clinical Outcomes: Findings From the ARTEMIS Trial. Circ Cardiovasc Qual Outcomes. 2020 May;13(5):e006182. doi: 10.1161/CIRCOUTCOMES.119.006182. Epub 2020 May 12.
Derived from this study: PubMed 32299284Doll JA, Kaltenbach LA, Anstrom KJ, Cannon CP, Henry TD, Fonarow GC, Choudhry NK, Fonseca E, Bhalla N, Eudicone JM, Peterson ED, Wang TY. Impact of a Copayment Reduction Intervention on Medication Persistence and Cardiovascular Events in Hospitals With and Without Prior Medication Financial Assistance Programs. J Am Heart Assoc. 2020 Apr 21;9(8):e014975. doi: 10.1161/JAHA.119.014975. Epub 2020 Apr 17.
Derived from this study: PubMed 32129795Fanaroff AC, Peterson ED, Kaltenbach LA, Cannon CP, Choudhry NK, Henry TD, Anstrom KJ, Cohen DJ, Fonseca E, Khan ND, Fonarow GC, Wang TY. Agreement and Accuracy of Medication Persistence Identified by Patient Self-report vs Pharmacy Fill: A Secondary Analysis of the Cluster Randomized ARTEMIS Trial. JAMA Cardiol. 2020 May 1;5(5):532-539. doi: 10.1001/jamacardio.2020.0125.
Derived from this study: PubMed 31721978Fanaroff AC, Peterson ED, Kaltenbach LA, Cannon CP, Choudhry NK, Henry TD, Anstrom KJ, Cohen DJ, Fonseca E, Khan ND, Fonarow GC, Wang TY. Association of a P2Y12 Inhibitor Copayment Reduction Intervention With Persistence and Adherence With Other Secondary Prevention Medications: A Post Hoc Analysis of the ARTEMIS Cluster-Randomized Clinical Trial. JAMA Cardiol. 2020 Jan 1;5(1):38-46. doi: 10.1001/jamacardio.2019.4408.
Derived from this study: PubMed 30620370Wang TY, Kaltenbach LA, Cannon CP, Fonarow GC, Choudhry NK, Henry TD, Cohen DJ, Bhandary D, Khan ND, Anstrom KJ, Peterson ED. Effect of Medication Co-payment Vouchers on P2Y12 Inhibitor Use and Major Adverse Cardiovascular Events Among Patients With Myocardial Infarction: The ARTEMIS Randomized Clinical Trial. JAMA. 2019 Jan 1;321(1):44-55. doi: 10.1001/jama.2018.19791.
D5130R00030\_CSP\_redactedLink provided by the sponsor.
D5130R00030\_SAP\_RedactedLink provided by the sponsor.

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Tracy Wang, MD, MHS, MSc principal investigator

Duke University

Eric Peterson, MD, MPH, FAHA, FACC study chair

Duke University

272 sites in 2 countries: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Study voucher card in people with Cost Sharing, Acute Coronary Syndrome, run by AstraZeneca at 272 sites in 2 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 6 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 1 Oct 2019. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 272 sites in United States, Puerto Rico. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 1 Oct 2019). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Kaplan-Meier Cumulative Incidence Rate of Major Adverse Cardiovascular Events (time frame: 12 months). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02406677, which also lists 7 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 1 Oct 2019.